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Quality Engineer

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Date: Jan 12, 2019

Location: Durham, NC, US, 27712

Company: Corning

Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people’s lives.

Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Scope of Position:

In this role, you will be reporting directly to the Quality Manager or designee, this position involves product team support for the manufacturing operations, provides quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. You will work closely with other functions within the organization (Manufacturing, R&D, CI, Quality, Engineering, Procurement and Marketing) and will be responsible for the quality of the product and process for the assigned product line(s).

 

Day to Day Responsibilities:

  • We look for you to provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
  • Provide Life Sciences help desk and customer complaint point of contact and problem resolution to include Questionnaires, Certificates, and Customer Surveys etc.
  • Facilitate investigation of Failure Investigation Reports (FIR), Situation Analysis (SA) and Health Hazard Evaluation (HHE) with clear documentation of corrective actions.
  • Lead discussions on blocked stock and open notifications in Material Review Board (MRB).
  • Support Life Sciences Corporate (Tewksbury) with Customer Notification Letters from plant projects as needed.
  • Assist with the investigation of Corrective & Preventive Actions (CAPA), notifications and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.
  • Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol development, review, approval and Control Plans.
  • Support Continuous Improvement activities and key plant projects.
  • Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans.
  • Implement validated inspection and metrology improvements and associated training.
  • Review and approve Project Design History Files.
  • Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards.
  • Serve as a resource for performing internal audits to ensure quality system compliance.
  • Able to react to change and perform other duties as assigned.

 

Travel Requirements:

  • Less than 10% domestic.

 

Hours of work/work schedule/flex-time:

  • Monday – Friday, standard business hours.
  • Some flexibility may be needed for training.
  • 24/7 manufacturing facility.

 

Required Education:

  • Bachelor’s degree in science or technical field. Prefer Engineering or Statistics preferred.

 

Required Years and Area of Experience:

  • Minimum of 3 years of manufacturing quality engineering experience in a highly regulated industry (medical device industry preferred.)

 

Required Skills:

  • Capable of the integration and application of user aimed manufacturing process documentation while meeting business and regulatory requirements.
  • Demonstrated technical writing skills.
  • Working knowledge of databases, including Access, spreadsheet applications, Microsoft Project, Minitab and word processing, to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
  • Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
  • Ability to make decisions regarding product disposition and corrective and preventive action effectiveness.
  • Able to give direction to accomplish work you're leading.
  • Knowledge of manufacturing processes and relevant statistical methods for quality assurance.
  • Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation.

 

Desired Experience / Qualifications / Skills:

  • Thorough knowledge of the regulatory industry requirements ISO9001, ISO13485, and Quality Systems Regulation CFR 21 part 820, GDP / GMP-Good Doc / Good Manufacturing Practices.
  • Six Sigma certification
  • ASQ Certified Quality Engineer
  • ERP system experience; prefer PeopleSoft.

 

Soft Skills:

  • Do you have the ability to influence individuals without authority and to motivate others within a project team?
  • Are you action oriented, make informed decisions, be self-motivated, capable of influencing without authority?
  • Are you an effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills?
  • Lead a team within a highly matrixed organization
  • Flexibility to assume ownership on projects and coordinate the efforts of others to complete project goals or participate on a team to support other project Leads; should also be able to effectively handle conflict.

 

This position does not support immigration sponsorship.

We prohibit discrimination on the basis of  race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, or veteran status or any other legally protected status.


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh